Caring Mills Menthol 4% Roll-on

Caring Mills Menthol 4% Roll-on
SPL v1
SPL
SPL Set ID f4308c74-0860-4265-aeaf-a01301cca27a
Route
TOPICAL
Published
Effective Date 2025-09-29
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol (4 g)
Inactive Ingredients
Glycerin Aloe Vera Leaf Carbomer 940 Camphor (natural) Aminomethyl Propanol Alcohol Arnica Montana Flower Water Isopropyl Myristate Calendula Officinalis Flower .alpha.-tocopherol Acetate Melissa Officinalis Leaf Arctium Lappa Whole Green Tea Leaf Ilex Paraguariensis Leaf Indian Frankincense Methyl Methacrylate/glycol Dimethacrylate Crosspolymer Fd&c Yellow No. 5 Fd&c Blue No. 1

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-09-01

Description

Caring Mills Menthol 4% Roll-On

Purpose

Topical analgesic


Medication Information

Purpose

Topical analgesic

Description

Caring Mills Menthol 4% Roll-On

Uses

Uses Temporarily relieves minor pain associated with: ■ arthritis ■ simple backache ■ muscle strains ■ sprains ■ bruises

Section 42229-5

Caring Mills Menthol 4% Roll-On

Warnings

For external use only

Directions

Adults and children over 12 years:■ apply a thin layer to affected area

■ massage into painful area until thoroughly absorbed into skin

■ repeat as necessary, but no more than 3 to 4 times daily

IF MEDICINE COMES IN CONTACT WITH HANDS, WASH WITH SOAP AND WATER

Children 12 years or younger:■ ask a doctor

Active Ingredient

Menthol 4%

Inactive Ingredients

aloe barbadensis leaf juice, aminomethyl propanol, arctium lappa extract, arnica montana flower extract, boswellia serrata extract, calendula officinalis flower extract, camellia sinensis leaf extract, camphor, carbomer, FD&C blue no.1, FD&C yellow no.5, glycerin, ilex paraguariensis leaf extract, isopropyl alcohol, isopropyl myristate, melissa officinalis leaf extract, methyl methacrylate crosspolymer, tocopheryl acetate, water

Questions Or Comments

Call 1-866-326-1313

Principal Display Panel

When Using This Product

When using this product

■ use only as directed. Read and follow all directions and warnings on this carton

■ rare cases of serious burns have been reported with products of this type

■ do not bandage tightly or apply local heat (such as heating pads) or a medicated patch to the area of use

■ avoid contact with eyes and mucous membranes

■ do not apply to wounds or damaged, broken or irritated skin

■ a transient burning sensation may occur upon application but generally disappears in several days

■ if severe burning sensation occurs, discontinue use immediately

■ do not expose the area treated with the product to heat or direct sunlight

■ avoid applying into skin folds

Stop Use and Ask A Doctor If
  • condition worsens
  • redness is present
  • irritation develops
  • symptoms persist for more than 7 days or clear up and occur again within a few days
  • you experience signs of skin injury, such as pain, swelling, or blistering where the product was applied

Flammable■ Keep away from fire or flame

If Pregnant Or Breast Feeding,

ask a health professional before use.

Keep Out of Reach of Children.

If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.


Structured Label Content

Uses

Uses Temporarily relieves minor pain associated with: ■ arthritis ■ simple backache ■ muscle strains ■ sprains ■ bruises

Section 42229-5 (42229-5)

Caring Mills Menthol 4% Roll-On

Purpose

Topical analgesic

Warnings

For external use only

Directions

Adults and children over 12 years:■ apply a thin layer to affected area

■ massage into painful area until thoroughly absorbed into skin

■ repeat as necessary, but no more than 3 to 4 times daily

IF MEDICINE COMES IN CONTACT WITH HANDS, WASH WITH SOAP AND WATER

Children 12 years or younger:■ ask a doctor

Active Ingredient (Active ingredient)

Menthol 4%

Inactive Ingredients (Inactive ingredients)

aloe barbadensis leaf juice, aminomethyl propanol, arctium lappa extract, arnica montana flower extract, boswellia serrata extract, calendula officinalis flower extract, camellia sinensis leaf extract, camphor, carbomer, FD&C blue no.1, FD&C yellow no.5, glycerin, ilex paraguariensis leaf extract, isopropyl alcohol, isopropyl myristate, melissa officinalis leaf extract, methyl methacrylate crosspolymer, tocopheryl acetate, water

Questions Or Comments (Questions or comments)

Call 1-866-326-1313

Principal Display Panel

When Using This Product (When using this product)

When using this product

■ use only as directed. Read and follow all directions and warnings on this carton

■ rare cases of serious burns have been reported with products of this type

■ do not bandage tightly or apply local heat (such as heating pads) or a medicated patch to the area of use

■ avoid contact with eyes and mucous membranes

■ do not apply to wounds or damaged, broken or irritated skin

■ a transient burning sensation may occur upon application but generally disappears in several days

■ if severe burning sensation occurs, discontinue use immediately

■ do not expose the area treated with the product to heat or direct sunlight

■ avoid applying into skin folds

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • condition worsens
  • redness is present
  • irritation develops
  • symptoms persist for more than 7 days or clear up and occur again within a few days
  • you experience signs of skin injury, such as pain, swelling, or blistering where the product was applied

Flammable■ Keep away from fire or flame

If Pregnant Or Breast Feeding, (If pregnant or breast-feeding,)

ask a health professional before use.

Keep Out of Reach of Children. (Keep out of reach of children.)

If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.


Advanced Ingredient Data


Raw Label Data

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